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Probe of Implant Maker Is Sought

October 13, 2006|From Bloomberg News

A former scientist at Mentor Corp. accused the Santa Barbara-based company of withholding unfavorable safety data from regulators considering whether to lift 14-year-old curbs on silicone breast implants, a consumer group said Thursday.

The group, Public Citizen, is urging the Food and Drug Administration to keep the restrictions and start a criminal investigation. An FDA official told the unidentified scientist that the data weren't requested by the FDA and weren't relevant, Public Citizen said in a letter to the agency.

"This new evidence that information has been illegally withheld from the FDA should prompt a new criminal investigation into Mentor's failure to promptly send the agency all new information bearing on the safety of silicone gel implants," Sidney M. Wolfe, director of Public Citizen's Health Research Group in Washington, said in the letter.

Mentor shares fell $1.19 to $47.69.

The former Mentor scientist told the FDA in June that the company understated the extent of silicone gel seeping out of the implant into the body and withheld evidence that the leaked gel becomes more dangerous over time, according to Public Citizen. Mentor also withheld data showing that the material holding the silicone was more susceptible to weakening than the company suggested to the FDA, the scientist said.

In 1992, the FDA limited use of silicone implants until scientific studies could address concerns raised about side effects. In 2003, a panel of outside advisors to the FDA recommended that the restrictions end. The agency hasn't issued a decision.

The FDA has investigated the scientist's allegations and "found no evidence of wrongdoing and nothing that would raise questions about the safety of the product under review or the integrity of the data submitted to FDA," spokeswoman Heidi Valetkevitch said in an e-mail.

The scientist, who worked for Mentor for 15 years, made the allegations after he was fired, Public Citizen said.

Mentor said in an e-mail that FDA officials visited the company in July, and "to our knowledge, all questions were answered to the satisfaction of FDA."

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